Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis

This study is a Phase IV clinical trial designed specifically to examine how older adults (aged 60 years and above) respond to Mirikizumab, a biologic treatment approved by the FDA for inflammatory bowel disease (IBD). Recognizing the limited clinical trial representation of older patients, this study aims to provide essential evidence on treatment effectiveness, safety, and patient experience within this specific age group, addressing an existing knowledge gap in clinical practice. The trial will enroll approximately 150 adult participants diagnosed with moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) across multiple academic and community healthcare settings within the United States. Enrolled participants will undergo treatment with Mirikizumab administered strictly in accordance with FDA-approved dosing guidelines, without comparator or placebo groups. Key measures of clinical improvement include standardized, validated scoring systems: the Crohn's Disease Activity Index (CDAI) for CD participants and the Mayo Score for UC participants. Additionally, validated biomarkers indicative of disease activity (e.g., CRP, fecal calprotectin) and standardized patient-reported outcome measures (Inflammatory Bowel Disease Questionnaire \[IBDQ\]) will be evaluated at specified intervals. Participants will attend scheduled visits at baseline (Week 0), and subsequently at Weeks 12, 24, and 48. At each visit, researchers will assess clinical status, collect biological samples for biomarker analysis, review patient-reported outcomes, and systematically document any side effects or adverse events associated with treatment. Safety will be carefully monitored by an independent Data Monitoring Committee (DMC), which will review collected safety data semi-annually. Procedures for adverse event reporting are rigorous, following strict regulatory guidelines to ensure participant safety. Comprehensive strategies to retain and support study participants include regular follow-up contacts, adherence monitoring, patient education initiatives, and flexible scheduling for convenience. Data collected throughout the trial will be securely managed using electronic data capture systems with strict confidentiality and quality control protocols in place. Statistical analyses will involve standard intention-to-treat (ITT) methods and mixed-model statistical approaches to accurately determine treatment effectiveness and safety outcomes. Ultimately, the findings from this trial aim to inform clinical care guidelines for older adults with IBD and enhance clinical decision-making by providing robust, real-world evidence specific to the aging population.